65 Years OlderElderTreeNCT02128789
Bring Communities and Technology Together for Healthy Aging
A study testing Elder Tree website in people with 65 Years Older and Requires IADL Support, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Technology has been created to help older adults age well in their homes, but adoption and acceptance have been slow. The researchers are developing a low-cost web-based technology, called Elder Tree, for older adults and caregivers to address key challenges older adults face, such as loneliness and isolation, falls… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- 65 Years Older, Requires IADL Support, Past Year History of Falls and/or Hospitalization
- What is being tested?
- Elder Tree website
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years or older
- In need of IADL support
- 1 years history or risk of hospitalization or falls
- Resident of the following counties Milwaukee, WI, Waukesha Wi or Richland County
- Must be able to read English at a 6th grade level.
Who cannot join
- Under 65 years of age
- Unable to read English
- Not a resident of the above listed counties.
Trial locations and contacts
1 site in 1 country.
About this study
Technology has been created to help older adults age well in their homes, but adoption and acceptance have been slow. The researchers are developing a low-cost web-based technology, called Elder Tree, for older adults and caregivers to address key challenges older adults face, such as loneliness and isolation, falls, loss of driving privileges, relapsing from proven falls prevention strategies, and unreliable home services. Elder Tree is being developed and tested with older adults and caregivers to identify, 1) usability issues such as font size, navigation and interface (audio, video,text) and 2) content and tailoring issues such as identifying local resources and events. This study will employ a randomized longitudinal design comparing a control group to an intervention group over a 12-month period. Investigators hypothesize that older adults using Elder Tree will experience greater independence and quality of life when compared to the control group. Investigators will use quantitative measures to determine how much our intervention improves: quality of life and health system use. These measures will help us to determine the cost effectiveness of Elder Tree. Investigators will recruit and test Elder Tree in 3 Regional Aging and Disability Resource Centers; one urban, one suburban and one rural setting, so to account for environmental and community differences. The older adult and their caregiver will be randomized to the same treatment group. Investigators will measure the effect over the 12 month intervention period and a 6 month follow-up period at 18 months.
- Being tested
- Elder Tree website
- Keywords
- Older Adults, Caregivers, Aging, Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elder Tree websiteOther
Elder Tree is a private, secure information, support and communication website developed for this study.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | Subjects receive usual care and support. No study intervention provided |
| Elder Tree Condition | Experimental | Elder Tree website. Subjects receive usual care, support and access to the study intervention website. Receives: Other: Elder Tree website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of older adult subjects with increased independence and quality of life from baseline to 18 months
Compared to the control group elders using Elder Tree will experience greater independence and quality of life and will have fewer unscheduled clinical and emergency room visits and hospital and nursing home stays.
Measured: Change in independence and quality of life will be assessed at 6, 12 , 18 months
Secondary outcomes (1)
Number of caregiver subjects with improved satisfaction
Compared to the control group, caregivers using Elder Tree will experience improved satisfaction, coping and appraisal.
Measured: Change in improved caregiver satisfaction will be assessed at 6, 12 , 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJun 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 65 Years OlderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128789
- Sponsor's protocol ID
- 2013-0171
- Other IDs
- 5P50HS019917-04, HS019917
- Acronym
- ElderTree
- Status last verified
- Oct 2016
- First submitted
- 26 Mar 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
PubMed 39360568Gustafson DH Sr, Kornfield R, Mares ML, Johnston DC, Cody OJ, Yang EF, Gustafson DH Jr, Hwang J, Mahoney JE, Curtin JJ, Tahk A, Shah DV. Effect of an eHealth intervention on older adults' quality of life and health-related outcomes: a randomized clinical trial. J Gen Intern Med. 2022 Feb;37(3):521-530. doi: 10.1007/s11606-021-06888-1. Epub 2021 Jun 7.
PubMed 34100234Gustafson DH Sr, McTavish F, Gustafson DH Jr, Mahoney JE, Johnson RA, Lee JD, Quanbeck A, Atwood AK, Isham A, Veeramani R, Clemson L, Shah D. The effect of an information and communication technology (ICT) on older adults' quality of life: study protocol for a randomized control trial. Trials. 2015 Apr 25;16:191. doi: 10.1186/s13063-015-0713-2.
PubMed 25909465
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bring Communities and Technology Together for Healthy Aging
- ClinicalTrials.gov ID
- NCT02128789
- Acronym / sponsor ID
- ElderTree / 2013-0171
- Keywords
- Older Adults, Caregivers, Aging, Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Technology has been created to help older adults age well in their homes, but adoption and acceptance have been slow. The researchers are developing a low-cost web-based technology, called Elder Tree, for older adults and caregivers to address key challenges older adults face, such as loneliness and isolation, falls, loss of driving privileges, relapsing from proven falls prevention strategies, and unreliable home services. Elder Tree is being developed and tested with older adults and caregivers to identify, 1) usability issues such as font size, navigation and interface (audio, video,text) and 2) content and tailoring issues such as identifying local resources and events. This study will employ a randomized longitudinal design comparing a control group to an intervention group over a 12-month period. Investigators hypothesize that older adults using Elder Tree will experience greater independence and quality of life when compared to the control group. Investigators will use quantitative measures to determine how much our intervention improves: quality of life and health system use. These measures will help us to determine the cost effectiveness of Elder Tree. Investigators will recruit and test Elder Tree in 3 Regional Aging and Disability Resource Centers; one urban, one suburban and one rural setting, so to account for environmental and community differences. The older adult and their caregiver will be randomized to the same treatment group. Investigators will measure the effect over the 12 month intervention period and a 6 month follow-up period at 18 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –Subjects receive usual care and support. No study intervention provided |
| Elder Tree Condition | Experimental | Other: Elder Tree websiteElder Tree website. Subjects receive usual care, support and access to the study intervention website. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years or older
- In need of IADL support
- 1 years history or risk of hospitalization or falls
- Resident of the following counties Milwaukee, WI, Waukesha Wi or Richland County
- Must be able to read English at a 6th grade level.
Key exclusion criteria (3 listed)
- Under 65 years of age
- Unable to read English
- Not a resident of the above listed counties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elder Tree websiteElder Tree is a private, secure information, support and communication website developed for this study. | Other | Elder Tree Condition |
Primary outcome
Number of older adult subjects with increased independence and quality of life from baseline to 18 months
Time frame: Change in independence and quality of life will be assessed at 6, 12 , 18 months
Compared to the control group elders using Elder Tree will experience greater independence and quality of life and will have fewer unscheduled clinical and emergency room visits and hospital and nursing home stays.
1 secondary outcome
Number of caregiver subjects with improved satisfaction
Time frame: Change in improved caregiver satisfaction will be assessed at 6, 12 , 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 39360568Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
- Derived from this study: PubMed 34100234Gustafson DH Sr, Kornfield R, Mares ML, Johnston DC, Cody OJ, Yang EF, Gustafson DH Jr, Hwang J, Mahoney JE, Curtin JJ, Tahk A, Shah DV. Effect of an eHealth intervention on older adults' quality of life and health-related outcomes: a randomized clinical trial. J Gen Intern Med. 2022 Feb;37(3):521-530. doi: 10.1007/s11606-021-06888-1. Epub 2021 Jun 7.
- Derived from this study: PubMed 25909465Gustafson DH Sr, McTavish F, Gustafson DH Jr, Mahoney JE, Johnson RA, Lee JD, Quanbeck A, Atwood AK, Isham A, Veeramani R, Clemson L, Shah D. The effect of an information and communication technology (ICT) on older adults' quality of life: study protocol for a randomized control trial. Trials. 2015 Apr 25;16:191. doi: 10.1186/s13063-015-0713-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elder Tree website in people with 65 Years Older and Requires IADL Support, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of older adult subjects with increased independence and quality of life from baseline to 18 months (time frame: Change in independence and quality of life will be assessed at 6, 12 , 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128789, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.